Arch Biopartners Submits Application to Health Canada to Conduct COVID19 Phase II Human Trial for Metablok to Prevent Lung and Kidney Inflammation
TORONTO, April 23, 2020 (GLOBE NEWSWIRE) -- Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF) a clinical stage company developing new drug candidates for treating organ damage caused by inflammation, today announced it has submitted a Clinical Trial Application to Health Canada for a Phase II human trial for its lead drug Metablok (LSALT peptide) to prevent lung and kidney inflammation in patients with COVID19.
The Phase II trial will be a multicenter, randomized, double-blind, placebo-controlled, proof of concept study of LSALT peptide. The primary endpoint is to prevent acute respiratory distress syndrome (ARDS) in patients infected with SARS-CoV-2 (COVID-19).
In the absence of a vaccine to prevent SARS-CoV-2 infection, survival rates and health care system capacity could both be improved with new treatments that target lung inflammation experienced by patients with severe COVID19.
A secondary endpoint of the Phase II study is to prevent kidney inflammation and injury, which also contributes to the mortality of COVID19 patients.
As a result of clinical interest to support the Phase II trial in the United States, Arch will be preparing an application to the U.S. Food and Drug Administration as well as other authorities within the American hospital system.
COVID19 is the disease caused by the novel coronavirus SARS-CoV-2 that emerged in China in late 2019. Patients with severe COVID19 develop progressive lung inflammation and acute respiratory distress syndrome that often requires mechanical ventilation and critical care. Patients with severe COVID19 also experience multi-organ dysfunction including acute kidney injury, cardiac failure and blood abnormalities. Currently, no vaccine or effective antiviral drug exists for SARS-CoV-2. Treatment of COVID19 has been primarily supportive and currently relies heavily on critical care.
About Arch Biopartners
Arch Biopartners Inc. is a clinical stage company focused on the development of innovative technologies that have the potential to make a significant medical or commercial impact. Arch is developing a drug library to produce new drug candidates that inhibit inflammation in the lungs, liver and kidneys caused via the dipeptidase-1 (DPEP-1) pathway.
Metablok is a novel peptide drug candidate and the lead DPEP-1 inhibitor in the Arch development pipeline. In August 2019, a scientific team led by Arch scientists Dr. Donna Senger and Dr. Stephen Robbins published a paper in the journal Cell describing a novel mechanism of action for organ inflammation. In the publication, DPEP-1 was identified for the first time as a major neutrophil (white blood cell) adhesion receptor on the lung, liver and kidney endothelium.
A total of 52 healthy, normal volunteers received dosing of Metablok during the Phase I human trial. In all cases, Metablok was well tolerated during this placebo-controlled trial and no significant drug-related adverse effects were observed.
Continuing under development in the Arch portfolio are: AB569, a potential new treatment for antibiotic resistant bacterial infections in the lung and wounds; and, ‘Borg’ peptide coatings that increase corrosion resistance and decrease bacterial biofilm on various medical grade metals and plastics.
For more information on Arch Biopartners, its technologies and other public documents Arch has filed on SEDAR, please visit www.archbiopartners.com
The Company has 59,882,302 common shares outstanding.
All statements, other than statements of historical fact, in this news release are forward looking statements that involve various risks and uncertainties, including, without limitation, statements regarding the future plans and objectives of the Company. There can be no assurance that such statements will prove to be accurate. Actual results and future events could differ materially from those anticipated in such statements. These and all subsequent written and oral forward-looking statements are based on the estimates and opinions of management on the dates they are made and are expressly qualified in their entirety by this notice. The Company assumes no obligation to update forward-looking statements should circumstances or management’s estimates or opinions change.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release
For more information, please contact:Richard MuruveChief Executive OfficerArch Biopartners, Inc. 647-428-7031